AZ: No Cupcakes for You!

An AstraZeneca memo forbidding sales reps to give cupcakes to patients was recently released by the "AZ Group of Seven" and published by Peter Rost on the Question Authority Blog:

From: Paskman, Andrea
Sent: Tuesday, May 01, 2007 4:49 PM
To: Danhoffer, Ronald E; Hardesty, Edward L: Russel, Joseph; Cioll Richard E (ONC DSM); Karcewski, Thomas M; Call, Teresa
Cc: Kelly, Shawn; Hagelbarger, Jeff A
Subject: FW: MUMs Programs
Importance: High

For those who have been asking about the MUMs program:

Recently, questions have been raised to both legal and compliance personnel regarding the sales force’s ability to distribute patient educational materials for the MUMs programs. During the month of May 2007, the sales force will be permitted to conduct such in-office MUMs programs, however the following provisions apply:

1. Approved patient education materials may be distributed to patients in the office on behalf of, and with the permission of , the HCPs
2. PSS may display patient education materials on a small table in the office waiting room
3. The provision of food, snacks, beverages, and/or flowers to patients is not permitted.

The future of the MUMs program and similar in-office programs is currently being evaluated. You will be notified once the evaluation is complete.

Despite the fact that some people mistakenly believe that HIPAA privacy regulations REQUIRE AZ to take this action, I beg to differ (see "On Cupcakes and HIPAA").

The AZ Group of Seven quoted this from internal sources:

Here is the source for our HIPAA research:

May a sales representative sit in on a patient's exam or treatment?

No — unless the physician has obtained a valid authorization from the patient to share the information for these purposes. A sales representative may sit in on a patient's exam or treatment only if the patient has signed a valid authorization expressly allowing the sales representative to do so. The physician should provide the patient with sufficient opportunity to read the authorization form and ask questions before the patient decides whether to provide permission.

To which I reply:

Reps in the examination room is a completely different scenario from reps in the waiting room, which is what I was talking about and presumably where AZ put the cupcakes.

Reps often do get invited into the exam room when patients are consulting with physicians under what's called preceptorship programs. In this case, HIPAA privacy regulations DO require express patient authorization.

Note, however, that it is perfectly possible that some reps may be acting under contract with physicians to assist in the provision of care (eg, medical device reps) -- these contracts are allowed under HIPAA, which refers to them as Business Associate Contracts (BACs).

In that situation, patient authorization is NOT required under HIPAA just as HIPAA does not require patient authorization for the doc to send blood samples to outside labs.

I would note, however, that very few pharma companies would ever enter into BACs because these are very serious contracts. Most opt to make sure that the HIPAA authorization is in place.

BTW, I have written some of these HIPAA-related guidelines for sales rep training at a very large pharmaceutical company, which shall remain nameless.

But the bigger issue is THIS REALLY SUCKS FOR PATIENTS!

I cannot see how it is perfectly OK for reps to feed pizza to docs, but not give cupcakes to patients! (For more on this topic, see "Free lunch for patients! Why not?")

It’s time that we patients stood up and demanded our share of the pharma giveaway program!

Citing HIPAA as an excuse for not giving patients cupcakes is a red herring. That law was never intended to leave patients in the cold while docs feasted on gourmet deli sandwiches!

It’s all because of pharma bloggers — Ed Silverman, Peter Rost, Jack Friday — that this memo was written!

Does anyone think that a cupcake could influence me to ask my doctor for a course of Arimidex? Certainly not!

On Cupcakes and HIPAA

Do certain pharmaceutical physician marketing practices violate HIPAA -- the Health Insurance Portability and Accountability Act -- specifically, the patient privacy regulations under that act?

This is a very big topic, but I'd like to focus on one small piece of it, which has to do with AstraZeneca, cancer patients, and free cupcakes!

My friend Ed Silverman over at the Pharmalot Blog recently wrote:

"Do you remember AstraZeneca's promotional campaign for its cancer meds? MUMS - Mothers United for Mammograms - was designed to promote awareness of the test, in part. The program was put together by the drugmaker's oncology team and emphasized distribution of pink-frosted cupcakes, along with pink carnations and pink Arimidex bags in which info can be stuffed." See "Taxing Question: How Did AstraZeneca Account For Pink Cupcakes Given To Patients?"

Ed then asks these questions:

"The cupcakes may seem innocent enough, but could they cause a legal issue for AstraZeneca? The cupcakes were distributed in doctors’ office and hospitals, by the thousands. And this raises a question - how were all those cupcakes accounted for? Did the drugmaker properly expense the cupcakes? Company policy prohibits paying for patient meals.

"And meals are only supposed to be provided to health care providers and their staff, not patients. But all attendees are supposed to be listed on an expense report. List a patient by name and you run into HIPAA issues. Would writing off thousands and thousands of pink cupcakes as a general business expense leave a bad taste in an auditor's mouth?"

Let me take on the HIPAA question first, because I have some experience in advising pharmaceutical companies about privacy regulations under HIPAA (see the VirSci Corporation We site).

Not many people understand HIPAA and who is subject to HIPAA (aka, "Covered Entities"). Simply stated, covered entities are physicians and those people employed by physicians to carry out medical operations; eg, physicians' staffs. The rest of us -- patients included -- are not subject to HIPAA's privacy regulations.

You (even physicians) and me and patients are completely free to identify ourselves by name and talk about our medical problems to anyone! HIPAA does not apply to us.

Consequently, anybody, including a pharmaceutical sales rep, can go into a doctor's office -- if invited -- and talk to patients in the waiting room and ask their names, what medical condition they have, etc. and none of that would violate HIPAA. It may violate the doc's or the pharma company's business ethics or our moral compasses, but it does not violate HIPAA.

Only if a sales rep asked a physician (or a physician staff member) the names of patients would there be a violation of HIPAA. And then, only the physician or his staff member would violating the law, not the rep.

BTW, pharmaceutical marketers routinely ask consumers for their names, what drugs they take, etc. You've undoubtedly seen the BRC cards attached to print ads in magazines. There's no HIPAA issue there.

About Expensing Free Lunches to Patients
Ed also cites AZ policy on legitimate business expenses:

Health care providers and staff who would benefit from the educational information being provided may be invited to attend. Because of the educational focus of these programs, spouses, other family members, and/or GUESTS MAY NOT ATTEND these discussions.

The IRS requires a complete list of attendees, business relationship, and the business purpose in order to demonstrate the business nature of the expense. This documentation supports both the deductibility of the expense for the Company and the non-taxability of the reimbursement to the employee. This information must be included on the expense report form.

This last bit is where Ed thought that the cupcake dispensing sales reps would have to get patient names. However, I don't believe providing food (even cupcakes) to patients violates AZ policy -- it just would not meet the requirement of a legitimate business expense by IRS.

I am sure that the cost of the cupcakes could easily be "hidden" under some other legitimate business expense or, better yet, the AZ reps could have given the cupcakes to physicians and suggested that they be put out in the waiting room along with the bags full of patient information to aid in the physician's medical practice. This would then be a legitimate business expense by IRS standards -- the good were given to the physician, not the patients -- and may even comply with PhRMA and AMA guidelines regarding gifts to physicians -- in so far as you can say that all this was medically relevant (cupcakes could be a stretch -- but if you can add flavors to make taking medicines easier, then cupcakes could induce people to read pamphlets).

The AZ policy Ed quotes concerns "lunch and learn" sessions, which patients would not generally be invited to because these sessions are NOT patient education sessions. I am sure, however, that pharmaceutical companies sponsor other educational activities that ARE designed for patients -- such as health fairs -- at which food may be served. Again, this would be a legitimate business expense. The way it could work is the same as the cupcake scenario I described above: give money to the hospital to support the health fair. in this case, the direct recipient of the cash is a legitimate BUSINESS contact, not patients.

I am not defending AZ's cupcake caper. I am merely pointing out that such marketing and "educational" activities can be done without violating HIPAA and without violating IRS business expense requirements (although I am arguing only that these practices don't seem to violate AZ' policies regarding legitimate IRS business expenses -- I'm not an expert in tax law).

The focus so far in this post has been about legality, not with what's "right and wrong." Is it wrong for pharma sales reps to wander around doctors' offices and hospital corridors seeking out physicians? That's not a HIPAA issue, it's a business issue for docs and pharma companies.

Docs can ask reps to leave a waiting room or not to talk with patients and pharma companies may have policies against talking to patients. Nevertheless, this is completely up to the doc and the pharma company and is not mandated by HIPAA.

The doc and the patient may be afraid of violating HIPAA and use that as an excuse to bar reps, but HIPAA even allows for "incidental" exposure of confidential medical information. For example, if a rep is invited into the back office and happens to see a patient's chart inadvertently left open on a desk, that could be "incidental" exposure under HIPAA and not violative of the law -- bad privacy practice to be sure, but not necessarily a violation of HIPAA. Once you invite the rep in, "shit can happen," but it's not necessary HIPAA-violation shit.

BTW, I have consulted with many pharmaceutical companies about HIPAA and made many HIPAA privacy presentations at industry meetings -- so I know a little more about this than the average person.

Is Big Pharma Shifty?

The allegations against Avandia have re-ignited the criticisms of pharmaceutical marketing. An Adweek article claimed that a recent poll conducted by Harris Interactive for the Pharmaceutical Safety Institute showed that "Consumers think Big Pharma is shifty as well as greedy."

Adj. shifty - 1. characterized by insincerity or deceit.

In other words, Big Pharma is a big fat liar!

According to Adweek:

"[The poll] documents the degree to which people don't trust the industry to disclose bad news about its wares. Asked how confident they are that drugmakers 'will eventually disseminate all information—positive or negative—that they have regarding the safety of their drugs,' few said 'extremely' (4 percent) or 'very' (10 percent). Thirty percent said they're 'fairly' confident, with another 27 percent 'somewhat' so. But even such lukewarm trust was more than could be mustered by the 29 percent who declared themselves 'not at all' confident of such disclosures. The numbers were nearly identical when people were asked how confident they are that companies will release news of adverse reactions to any of their drugs 'as soon as they have such information.' "

"Given such distrust, one might expect consumers to shun direct-to-consumer sales pitches for prescription drugs. Instead, the survey shows many find such ads useful."

Adweek set up false expectations by looking at the data as a glass half empty (29% "not confident) rather than half full (30% "fairly confident").

Consumers, it seems, can recognize advertising for what it is: "carefully wrought bullshit," which is distinguishable from lying in that the bullshitter has a complete disregard for facts, according to Harry G. Frankfurt, a Princeton University professor of philosophy who authored the book "On Bullshit" (see "Is Pharmaceutical Marketing BS?".

"[The bullshitter's] eye is not on the facts at all," says Frankfurt, "as the eyes of the honest man and of the liar are, except insofar as they may be pertinent to his interest in getting away with what he says…this indifference to how things really are—that I regard as of the essence of bullshit."

In light of this distinction between lying and BS, I offer this second definition of "shifty," which I found online along with the first:

Adj. shifty - 2. Able to accomplish what is needed; resourceful.

Now, that describes marketers, including pharmaceutical marketers, to a tee. What Big Pharma needs is to sell product like any other capitalist enterprise. Marketing is a tool Big Pharma uses to accomplish that which is needed. Therefore, it should not be news to anyone that pharmaceutical marketers are "shifty" and as the poll shows, most consumers realize this and can live with it (they think drug ads, despite being shifty, are useful). There's no contradiction here.

Being shifty, you can't expect pharmaceutical marketers, therefore, to be completely transparent about drug side effects -- not if you leave it up to them, that is. And because it is so important to be transparent as possible about the risks of drugs as well as the benefits, we have laws that regulate direct to consumer (DTC) and physician promotion by pharmaceutical companies. The FDA is primarily responsible for enforcing these laws.

In Avandia's case, the FDA did repeatedly warn GSK that it was being "shifty" about the drug's side effects -- it wasn't lying, but it wasn't being completely sincere (transparent) either.

In this age of risk-benefit analysis, everyone -- depending on which side of the spectrum they are on -- overemphasizes one side or the other of the equation.

Industry proponents are guilty of overemphasizing the benefits to make the risks look more palatable. Bob Erhlich of DTC Perspectives, for example, claims in relation to Avandia-caused deaths that "Those deaths [attributable to increased risk of MI] pale in comparison to lives saved. That part of the story gets lost because 'greedy uncaring drug company' makes better copy."

No drug I know of has been approved on the basis of saving lives as the endpoint of a clinical trial. Outsiders and consultants like Erhlich can make the "saves lives" claim, but pharmaceutical marketers cannot, thank God!

Unfortunately, none of this helps patients understand how to evaluate the risks and benefits of drugs.

Avandia: Enough Blame to Go Around

Whenever a widely promoted and blockbuster Rx drug is found to adversely affect some patients, many people focus all or most of the blame on pharmaceutical marketers, sales force and other greedy pharmaceutical executives.

Avandia is no exception to this "rule" of "blame sales & marketing first, ask questions later."

For example, take this recent posting by Roy M. Poses MD on the Healthcare Renewal blog:

"Once again, it appears that a drug company was pushing one its products beyond what the clinical research evidence supported."

I find this claim disturbing. The way I interpret this remark is that GSK made efficacy (benefit) claims beyond what the evidence supports. This is different than saying it tried to gloss over the adverse side effects, which is what the FDA warning letters (mentioned in a recent NYT article) say. The FDA never, to my knowledge, claimed that GSK was making unsubstantiated benefit claims.

This is an important distinction, because any decision by the FDA to request that Avandia be taken off the market will be based on how the risks stack up against the benefits. Other commentators -- including Bob Ehrlich -- also point out that the benefits of Avandia may outweigh the risks:

"In my view, here is another useful drug accused of being dangerous in the unrealistic desire for risk free medications...Properly warned, patients and their physicians need to weigh the risk and benefits of any drug. In some of those carefully considered cases, patients will still die because of a reaction to a drug intended to make them better. That has and always will be the case. Those deaths pale in comparison to lives saved. That part of the story gets lost because 'greedy uncaring drug company' makes better copy." [DTC Perspectives Issue 262]

What GSK marketers may be guilty of -- and what the FDA has warned them of repeatedly -- is underplaying the risks, not over hyping the benefits.

One could make the argument that Avandia, Vioxx, and other drugs should only be marketed to a subset of consumers who can tolerate the known risks. This was the gist of a comment made to a Pharma Blogosphere post on this subject by "Insider" -- the anonymous blogger at Pharma Gossip:

Avandia (and Vioxx, possibly) may be good medicine for a small sub-group of patients - but should not have been "pushed" by mass marketing for all patients with diabetes (or OA in Vioxx's case).

R&D's success has been turned into failure by "over-Sales&Marketing" due to Senior Management greed/need for a blockbuster.

I acknowledge this point, but suggest that this puts the FDA squarely in the middle of the debate. FDA could have limited Avandia's approved-for-marketing indication to a subset of patients or excluded a subset, such as patients with with Congestive Heart Failure (CHF). In fact, the Avandia label includes data showing that Avandia can people with CHF can suffer adverse cardio events including heart attacks.

The point is, GSK had approval to market the drug to as wide an audience as possible -- virtually anyone with Type II diabetes. If there were known problems with a subset of patients, then it is up to the FDA to restrict the marketing to exclude that subset as it has done with a number of other drugs.

[Note: Usually, drugs are first approved for a limited indication and eventually that approval is widened to include more indications based on new data submitted. Unfortunately, the data that is used as the basis of new indications has more to do with efficacy than with safety. Again, the FDA must accept some responsibility for this wrong-headed way of expanding a drug's indication.]

Perhaps physicians also are partly to blame for not monitoring their patients closely enough. Look carefully at the following table that is included in the Avandia package insert, which all physicians should read (click on it to see an enlarged version for easier reading):

While this data involves a small number of people, I can easily see that the CHF group suffered 5 MIs vs 2 MIs for the control group. Duh! Even a non-physician might find this worrisome.

Yes, pharma marketing & sales may use T&A to influence physicians to over prescribe or prescribe a medication to the wrong patients (see, for example, "Dumb Blonde Reps vs. Slovenly Genius Reps") , but, hey! when is it time for physicians to take some responsibility for their actions?

[NOTE: Speaking of physician accountability, I can only guess that electronic medical records and ePrescribing hasn't gained much traction with physicians because of their fear of "outcomes" monitoring and being held accountable for outcomes. Of course, pharma is complicit in this attitude and would rather not have its drugs' outcomes monitored electronically and instantly! But that's another topic.]

Maybe even patients are partly to blame. When was the last time YOU read a package insert. Yes, it's often incomprehensible (see XXX), but patients often don't even read the patient section of a drug's label, which is easy to read as opposed to the technical part of the label designed for physicians. The Avandia label includes such a patient version, which states clearly:

Before taking AVANDIA, tell your doctor about all your medical conditions, including if you:
• have heart problems or heart failure. AVANDIA can cause your body to keep extra fluid (fluid retention), which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.

Only so much blame can be placed on the drug company and marketers for unduly influencing physicians and patients. This is not to say NO blame should be placed on GSK, only that there is enough blame to go around and it's time that regulators, physicians, and, yes, patients, step up and accept some responsibility!

In our jaded society it's too easy to blame the bogey man, big bad pharma, greedy corporate executives, marketers, or anyone else rather than oneself. Let's grow up already!

GSK May "Step Into the [DTC] Void" to Defend Avandia

According to a Wall Street Journal article, a Glaxo spokeswoman said the company isn't planning consumer ads defending Avandia, but won't rule them out, either. "At the moment, there is an information vacuum, and GSK may need to step into the void," she said.

Perhaps "vortex" is a better word than "void" in this case.

GSK coincidentally took "a short break" from U.S. Avandia ads when the safety concerns arose. Although GSK claims this move was unrelated to the recent safety concerns, one has to imagine that GSK knew full-well what was coming.

Although GSK is cautious, and rightly so, about "filling the void" with alternative Avandia safety data for consumers, it has no such qualms when it comes to propagandizing among physicians.

According to the WSJ article:

In meetings with doctors, Glaxo sales representatives are focusing on data from a large clinical trial called A Diabetes Outcome Progression Trial, or ADOPT. "We are reassuring physicians about the safety data we have, particularly looking at ADOPT," said Alice Hunt, a Glaxo spokeswoman.

This strikes me as "deja vu all over again."

Merck tried a similar "dodge ball" tactic of diverting doctors' questions about the safety of Vioxx and focusing their attention on "more favorable" data.

It seems that GSK is already breaking my Rule #1 for handling its Avandia crisis: Don't start training Avandia sales reps to "dodge" questions from physicians (see "Advice to GSK on Handling the Avandia Avalanche: Don't Do What Merck Did").

I expect Rule #5 to be broken next when GSK steps into the void: Don't run TV ads telling us that "patients come first"

Dumb Blonde Reps vs. Slovenly Genius Reps

Ed Silverman over at Pharmalot posted a fun little item about a poll that Cafe Pharma is currently running.

Ed asked "Do Good-Looking Reps Do Better?" or rather that was the gist of the poll.

The devil is in the details. Here's what the poll asked:

Which type of rep gets the best results? An average looking rep that knows their products and can sell? or A super attractive rep that is an idiot and can't sell?

Only 16% of respondents chose the super attractive rep option.

Unfortunately, this survey can't possibly yield any meaningful insights.

To sell (ie, "do better" or "get best results"), you first have to get in the door. So, a better question would have been: Do attractive reps get better access to physicians than do slovenly, but knowledgeable, enthusiastic piglets?

I think a lot more than 16% would answer "Yes" to that!

Another, more meaningful question would have been: Do reps -- attractive, plain, or sloven -- who bear gifts -- pizza, sandwiches, cupcakes -- get better access than those who come empty-handed?

Again, I think the pizza-delivery rep would have no problem getting in the door to most doctor's offices.

Good looks and pizza are very visible attributes, in plain sight. You see the cleavage, you open the door. You see the pizza, you open the door. It's Pavlovian!

Product knowledge and enthusiasm, on the other hand, are invisible. How does the doc (receptionist actually) know if the rep is knowledgeable about products? Only if the doc/receptionist lets him/her in the door and let's the rep speak.

But you can't get in the door without the cleavage or without the pizza!

For the knowledgeable Yossarian reps out there, It's a Catcha 22 ah!

Podcast Today! Mack vs. Ehrlich/Blogs vs. DTC

Listen to a FREE! live podcast today at 1 PM Eastern Time!

Blogs vs. DTC: What's Best for Consumers?
Exploring Blogs as a Counter to Other Sources of Drug and Medical Information

• Guest: Bob Ehrlich, Chairman, DTC Perspectives, Inc.
• Live Podcast Date: Thursday, May 24, 2007, 1 PM Eastern US time
• Duration: Approx. 35 minutes

Go to the Pharma Marketing Talk Channel Page to listen live or to access the archived audio after the show.

Background
While blogs are now aimed primarily at industry insiders, one has to wonder when it will be a dominant consumer tool aimed at reviewing drug performance, side effects and risks. Blogs on drug selection may soon be a key tool in spreading word of mouth on new drugs.

Consumers will learn to accept blogs as a counter to other sources of medical information, DTC included. This will be a messy process, because some blogs are factual and some are based on erroneous opinion or data. Drug companies need to take blogs seriously because consumers increasingly use them and will rely on them as much as main media for information. No one said the new world of technology would be easy. For the drug industry used to tight control of information, the blog world could be a nightmare to harness.

Bob Ehrlich
Bob Ehrlich is the CEO of DTC Perspectives Inc., the only company dedicated to studying direct-to-consumer marketing and advertising for the health care industry. Bob started DTC Perspectives in 2000, after a long career in consumer and pharmaceutical marketing at Warner Lambert.

In 1997 Bob was on the launch team for Lipitor, now the most prescribed drug in the world. He was voted one of the 50 top marketers in the United States by Advertising Age for that work.

Bob has consulted with many of the top pharmaceutical companies since he started DTC Perspectives. Clients have included AstraZeneca, Sanofi-Aventis, Lilly, Organon, and Allergan. Bob is well-known in the DTC industry for his frequent talks and his weekly email column is read by over 3000 industry professionals.
Some topics to be discussed:

• Are consumers turning towards blogs to get information about drugs and medical treatment options? Are these primarily patient/consumer blogs or also physician blogs?
• Are blogs inherently less credible than other sources of drug information on the Internet? If so, how so?
• Many patient blogs offer opportunities to be "harnessed" by pharmaceutical marketers. What dangers do marketers face when getting involved in the blogosphere either by placing ads on blogs or more pro-actively engaging in the conversation?
• How can pharmaceutical companies relinquish some control over content to enable to better co-operate with bloggers?

Temple vs. Nissen: Blood Rematch

Bob Temple, director of the Office of Medical Policy at FDA, admits that "some of the withering criticism of the agency is getting under his skin," according to Ed Silverman over at Pharmalot blog.

With the brouhaha over Avandia and the links in the press to the Vioxx case, FDA senses that the same band of renegade scientists are after their scalps. Temple in particular is feeling the heat. As one commenter to the Pharmalot post puts it: "Somehow I can't work up any empathy for Dr. Temple. His 25 years at the FDA have coincided with the deterioration of the agency."

"It's a particular subset of people who do that," said Temple referring to those critics that "get under his skin." "A lot of them over the years, I've considered friends. But I'm probably re-evaluating that." Temple was quoted in a RPM Report.

After 25 years at the FDA and with a possible Democratic administration looming. Temple may be positioning himself for retirement and a cushy new job with the pharmaceutical industry -- maybe even the new president of PhRMA. It could happen!

Among Temple's list of "friends" under "re-evaluation" include:

• Steve Nissen
• Curt Furberg

It's interesting that Temple singles out two guys who have been instrumental in the fall of Vioxx and now threaten Avandia.

Dr. Steve Nissen, of course, is the prominent Cleveland Clinic cardiologist whose analysis linked the widely used diabetes drug Avandia to higher risk of heart attack (see "Sequel for Vioxx Critic: Attack on Avandia"). Nissen also helped raise early safety concerns about Vioxx.

Dr. Curt Furberg, a health policy professor at Wake Forest University, was booted from an FDA drug-safety committee after criticizing Pfizer for some drug-trial practices. "Clearly, there are parties that would rather not see me there," Furberg said. Temple might have been a "subset" of those parties.

Furberg had spoken against Cox-2 inhibitors such as Vioxx, Celebrex and Bextra. "Basically, we showed [in an unpublished study] that [Pfizer's] Bextra is no different than Vioxx, and Pfizer is trying to suppress that information." Bextra was later withdrawn from the market.

Two days after Dr. Furberg’s remarks were published in the New York Times the FDA "disinvited" him from an advisory panel meeting that examined the safety of Cox-2 inhibitors. FDA said Dr. Furberg could not be expected to be objective and Pfizer said it had nothing to do with his removal. The FDA has had problems with other physicians on its staff and has been accused of dragging its feet regarding studies of Vioxx and other Cox-2 inhibitors.

Furberg reapplied to the FDA panel three months after his ouster and was approved. FDA officials had no comment on the reason for his reinstatement. It could be that Senator Grassley had something to do with his re-instatement.

Is drug recall history repeating itself? Does the FDA have something to hide about Avandia as it was accused of doing with Vioxx? Temple's remarks may be the tip of the iceburg:

"The [gentleman] doth protest too much, methinks."

Alli Ad Campaign Promises Honesty, But Does It Deliver?

Do you have a "extra pair of pants" with you today! GSK recommends you do when starting a regimen of its over-the-counter diet pill alli! But you might also sh*t your pants when you hear how much GSK is spending on its Alli ad campaign this year -- $150 million!

I think I read that right in the WSJ article "Company Touts Over-The-Counter Diet Pill."

But the year is nearly half over! On an annual basis then, GSK is spending closer to $300 million promoting this product!

I've blogged about the pooping-in-pants side effect of alli before (see "Alli Oops! I Just Pooped Myself!"). It's going to take some effective marketing BS to counteract that!

And what's GSK marketing strategy?

Is Alli Honesty the Best Policy?
"We've done everything to go out of our way to be honest," said Steve Burton, vice president of the weight control division at GlaxoSmithKline Consumer Healthcare. "We're taking a very different approach than the fad diets people are constantly exposed to."

Burton himself pooped his pants when taking alli, so he feels consumers' pain.

How honest GSK will be about alli remains to be seen, especially after taking a loss because of the Avandia Avalanche (see "Advice to GSK on Handling the Avandia Avalanche: Don't Do What Merck Did"). GSK is "counting on alli to become a star money maker." It must be counting faster now!

In my Alli Oops! post back in February, I pointed out that the alli web site was less than honest about bringing the pooping side effect -- which may affect up to 50% of alli users -- to the front burners of the site. NOTE; Don't go to www.alli.com -- that's an ad portal site obviously not owned by GSK. Go to www.myalli.com.


The honesty is really all about the amount of weight you can lose taking alli, not about the amount of poop you will make in your pants!

The home page of the site says: "it's time for an honest voice."

But I find that aside from burying the pooping side effect deep within the site (I'm not going to get into that again here), this site is FAR FROM HONEST!

It includes a "message board," which makes it one of the first pharmaceutical product sites that purports to incorporate "honest" "social networking" tools for visitors. This board is probably built from GSK's experience with the site Question Everything, which I reviewed previously (see "Question Everything"). I found that site less than honest about the amount of weight you can lose taking alli. Read my post and see for yourself.

The current incarnation of message boards on the myalli.com site gives me the willies -- in less than one second I have come across a post entitled "Looking Forward to a Real Chance" supposedly written by a real person, an ordinary "Joe consumer." I seriously question the authenticity of this guy who calls himself "Calamari Slim."

Why do I believe Calamari Slim is really a shill for alli, probably a copy writer in the alli PR agency?

1. The title of this post, like most of the titles for other posts, sticks pretty close to the advertising play book and doesn't sound like something a "real" person would use. It's difficult to come up with catchy titles for essays!

2. The 782-word posting, which is rather long-winded for a typical message board posting, contains absolutely NO spelling errors and only one typo: a double "and", which even a PR copy writer can be guilty of from time to time. But no mis-spellings? I can't believe it. Even when I use a spell checker, my posts often end up with several wayward words.

3. The grammar and style is impeccably beautiful! Here's an excerpt:

I came across this site by accident. I had heard of Xenical, but with all the other health problems I'd had as of late, taking a "vanity diet pill" that I knew wasn't going to be the miracle cure-all. But it seems that things change, and that the fortune's wheel has come in my direction, a final chance to slim down...or (and I have to admit this to myself) end up dying in a pathetic and pitiless manner that I could have avoided.

I have too much riding now to miss this chance. I know many of you are thinking the same thing. We will succeed - we have to, for one reason or another, whether it's slimming into those old jeans that used to fit, or to be able to look good on the beach again, or even to be able to live past the age of 50. The drug mentioned here isn't the cure-all. It's a supplement, just as PT (physical training) is. Just as self-restraint is. Just as a positive mindset is. They're all pieces of the puzzle, parts of the core, and we'll do this, either separate or together (I recommend together, since we've all come here to the site).

You tell me if you think this is something a "real" person would write. Remember, I picked this post virtually at random!

4. The content of the post tracks perfectly with GSK's marketing strategy! This is just too much of a coincidence for me!

If the product website is any indication of alli ad campaign honesty, then I say that GSK has a long way to go to deliver on its promise!

Advice to GSK on Handling the Avandia Avalanche: Don't Do What Merck Did

Dear GSK,

Already the press is making strong analogies between Avandia and Vioxx (see "Sequel for Vioxx Critic: Attack on Avandia"). But if you are smart, Avandia can still come out of this with a slap on the wrist. Here are a few suggestions for what you should do and, more importantly, what you should NOT do. I base a lot of this on the mistakes that Merck made handling the Vioxx situation:

(1) Don't start training Avandia sales reps to "dodge" questions from physicians as Merck did (see "Get a Load of Those Gams!"). Instead, be proactive with physicians and show them the data you presented to the FDA, which seems to believe these data will vindicate Avandia. Reach physicians quickly through the Internet and avoid having to retrain all your reps to handle this -- they will only f**k it up anyway.

NOTE: Some of GSK's reps have already thrown in the towel anyway, so they cannot be relied upon to take up the cause. A recent post by a rep at Cafe Pharma sums it up: "Face it, once you're on World News Tonight and all the local news shows.....you're done. It's not a class effect, they are only naming Avandia. That's the only name the dumb consumer will hear. Takeda made a boatload of money at Avandia/met expense last year and it looks like it will happen again this year.....amazing!"

P.P.S. I know GSK likes to use sales reps as spokespeople for the good the industry does (see "Sales Reps Make Poor Spokespeople"), but in this case I wouldn't play that card. Your sales reps have a lot of dough to lose if Avandia tanks. They are not unbiased and I think even "dumb consumers" can see this.

(2) Take a page out of Pfizer's book: Keep Avandia on the market and hire the best cardiologist there is -- actually it will have to be the second best; the cardiologist who dissed Avandia in the NEJM (Dr. Nissen of the Cleveland Clinic) is considered one of the best, if not best -- to start a massive study of the cardiovascular effects of Avandia (with the goal of proving that it has no adverse CV effects, of course). Some people thought Pfizer was crazy when it followed this strategy for Celebrex (see "Is Pfizer Crazy or What?"), but that product has survived, albeit a little beaten up.

(3) If there is something you know and are keeping it secret, don't. The last thing you want is a "who knew what, when" investigation by Congress. Merck tried to hide data and was caught with its hand in the cookie jar (see "Merck's Hand in the Cookie Jar").

(4) This is a corollary to #3: Don't mislead the FDA like Merck did (see "Merck Misled FDA According to NJ Jury"). It could bite you in the ass at the jury trials that are sure to follow. FDA is your best friend and friends don't let friends go out on a date with Congress without protection!

(5) Don't run TV ads telling us that "patients come first" like Merck did (see "Patients Come First?"). First of all, the jury is still out on that premise. Secondly, who's going to believe you? Better to save $20 million for something more useful, like inviting us pharma bloggers on a junket or something like that (just kidding folks!). Or you can give us a new installment of "Clarence" the R&D Guy. I like him (see "Clarence," GSK's R&D Guy, Trumps "Jamie," Pfizer Viagra Guy!).

(6) Whatever you do, don't tell us how much it costs to develop drugs like Avandia and imply how lucky we are to have these drugs. Now's not the time for that.

That's my advice for now. Let's see how this plays in Peoria (and Congress) before I offer any other suggestions.

Good luck.

Sincerely,

John Mack

P.P.P.S. I almost forgotone important piece of advice!

(7) Don't fire any whistleblowers! According to the WSJ article, "Yesterday, the Senate Finance Committee chairman, Montana Democrat Max Baucus, and Sen. Grassley sent a letter to Glaxo mentioning 'reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia.'" You can silence outside medical professionals, but don't attempt to silence or fire or marginalize internal professionals who may become whistleblowers. Assume that your employees are saving incriminating evidence and some day may reveal it all to Dr. Peter Rost, who currently has a full pipeline of pharma whistleblowers and is undoubtedly looking for more!

Disclosure: John Mack does not own stock in GSK, Takeda, Merck or Lilly u nless it is through Mutual Funds holdings. John Mack also is not currently under contract to consult for GSK, Takeda, Merck or Lilly.

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Innerstate: A Correction and Further Criticisms

This morning, I posted an item about Centocor's documentary INNERSTATE and reported that SEIU Local 32BJ filed a lawsuit against J&J claiming that the company used pricing and marketing practices that lead to excessive reimbursements by Medicare, private insurers, and patients. (see "The Innerstate DVD. Is TV Next?"). I also implied that Centocor "hid" this fact and referred to a Local 32BJ protest at a screening of INNERSTATE as merely a labor issue.

I'd like to make some corrections and also add a bit to the story.

First, a spokesperson for the union wrote me an email and clarified who initated the law suit:

"I write to correct today's entry, which says SEIU Local 32BJ filed a lawsuit against J&J. The plantiffs in the case include the federal government, various states, and other entities, but NOT Local 32BJ. We just reported on it based on court filings."

Michael Parks, Centocor's Director of Public Relations, and Executive Producer of INNERSTATE, made this further clarification:

John, always enjoy reading your posts and I personally appreciate your diligence in seeing a topic through.

That said I want to take an opportunity to clarify some of the statements made in your most recent post.

We have been sending out free DVD’s since the premiere in New York City to anyone who requests a copy. As you know, this film had a limited release and will only be screened in 14 cities. Therefore, we felt it was important that we made the film readily available by DVD for the majority of people who lived beyond the area of the screenings and for those who simply could not attend.

With respect to your question about InnerState appearing on TV, I regret to inform you that we have no plans to take it to take it there.

Regarding your “protest”, it is important that you understand the full picture before jumping to conclusions. As you know, the pharmaceutical industry must adhere to very rigorous regulatory standards that have been put in place by the Food and Drug Administration (FDA). Adherence to these standards is something Centocor takes very seriously and we go to great lengths to ensure it is done properly. InnerState is no exception. These standards are often open to interpretation by regulators and they can apply these standards in a way that is not obvious to the general public. In order to fully disclose our role in the film and to ensure that we are delivering a very responsible and fair public health message, we made the decision to include the statements by Dr. Schaible and to include the Medication Guide for REMICADE in the DVD packaging. The Medication Guide is a risk management document for patients and is mandated by FDA regulation. A substantial majority of the information you describe discusses appropriate risk information and encourages viewers to have informed conversations with their doctors.

Lastly, you are correct that Service Employee International Union (SEIU) Local 32BJ demonstrated at the King of Prussia screening of InnerState. However, SEIU has not filed suit against Centocor or its parent company and demonstrations remain related to a labor issue with one of Centocor’s third party contractors. SEIU states on their own fliers “SEIU Local 32BJ has a dispute with [named company, not Centocor] and no other employer”. As I stated to you before, Centocor cannot and will not take a position on this matter.

I hope this offers some context around the issues you raise in your post.

I regret the confusion I may have caused.

Regarding the Medication Guide in the DVD package, I will take Mr. Parks at his word when he says Centocor included it to "fully disclose our role in the film and to ensure that we are delivering a very responsible and fair public health message." Certainly, they are not hiding the fact that Remicade is the "biologic therapy" in quetion. The main point is that the circle connecting the unbranded movie to the branded message is now closed.

Since the DVD was released at the same time the movie came out, I suppose my little analogy with Hollywood films is now null and void! The fact that the movie will NOT make it to TV puts more holes in the analogy. O well!

SEIU Local 32BJ Protests INNERSTATE to FDA and PhRMA
But Local 32BJ still protests INNERSTATE and has sent letters to the FDA and PhRMA complaining that Centocor is violating PhRMA's Guiding Principles on DTC advertising. I reproduce the bulk of that letter here:

May 21, 2007
PhRMA Office of Accountability
950 F Street, NW, Suite 300
Washington, DC 20004

VIA FASCIMILE: (202) 775-0258

Dear Sir or Madam:

We write to express our dismay at the release and marketing of Centocor’s movie, Innerstate, which features individuals with conditions treated by the company’s drug, Remicade. Centocor is a subsidiary of PhRMA member Johnson & Johnson ("J&J"). While Centocor labels Innerstate a documentary, Remicade's dominant market position and materials distributed at Innerstate screenings suggest that the movie serves as a promotional vehicle for the company’s product. In light of this, we believe PhRMA should investigate whether J&J has violated the Guiding Principles on direct-to-consumer ("DTC") marketing to which PhRMA members have agreed, and take appropriate action.

Innerstate as DTC advertising
PhRMA’s guidelines on DTC advertising are aimed at television and print advertising. DTC television advertising is defined in the guidelines as "a portion of television air time on broadcast or cable television that is bought by a company for the purpose of presenting information about one or more of the company’s medicines." Although Innerstate has so far only been shown in movie theaters, we believe the spirit of the guidelines should cover such a project, whose screenings are paid for by Centocor and which will also be released on DVD. Indeed, one reason the PhRMA guidelines do not explicitly cover movies may be that their authors never envisioned the existence of a film like Innerstate. According to the New York Times, industry experts "could remember no other documentary conceived of and financed start-to-finish by a drug maker."

Another criterion for DTC advertising is the presentation of medication information. While Innerstate does not specifically mention Remicade or Centocor, Centocor distributed a Viewer’s Guide to the film at its King of Prussia, Pennsylvania, screening on April 28, 2007 that did. The Viewer's Guide profiles the three patients featured in the film, and states in each profile that the patient was treated with Remicade. Following the patient profiles is an essay titled "A Message from Centocor" by the company’s Vice President of Medical Affairs, which reveals that Centocor makes Remicade, and discusses many of the drug’s possible side effects. Centocor also included the entire Medication Guide for Remicade in the booklet.

No other biotech drug was mentioned in the Viewer’s Guide.

At the screening, Centocor also distributed a survey form with an offer for a DVD of Innerstate. The fine print gives Centocor and other Johnson & Johnson affiliates the right to send to survey participants information about their products "and the conditions they are approved to treat," as well as experiences of patients treated by those products. Centocor did not offer to provide information on competing drugs or treatments.

It is important to note that there is no other way to watch the movie at this time than to attend a Centocor-sponsored screening, and the DVD is available only to attendees after talking to a member of the event staff.

In light of the above, SEIU Local 32BJ believes that the Viewer's Guide and survey form distributed at the Innerstate screening constitute DTC print advertisements, and the movie a DTC broadcast advertisement. We do not appear to be alone in this view. The New York Times called the movie "an unusual form of soft-pedal marketing of a blockbuster drug, Remicade." The Philadelphia Inquirer reported that "even without naming Remicade, Centocor stands to gain from increased disease-awareness because, as the market leader, it tends to capture most new prescriptions."

Centocor would have us believe that it aims "to elevate the voices, stories and successes of patients, as well as to broaden awareness of immune-related diseases." But the promotional materials given at the screenings suggest an ulterior motive. Dr. Jerry Avorn, a Harvard Medical school professor and author of Powerful Medicines, commented that Innerstate "is a whole new dimension in direct-to-consumer advertising. What makes me edgy about it is if it is going to be a commercial, you should know it’s a commercial. I’m very troubled by the blurring of the lines between advertising and patient education."

PhRMA’s Guidelines as Applied to Innerstate
Since Innerstate is clearly, in our view, a DTC advertisement, Centocor should follow PhRMA’s Guiding Principles on such advertisements. But Centocor appears to have violated several of the guidelines.

Principles #3 and #4 ask companies to educate consumers about the medicine being advertised, and to indicate if it is a prescription drug. Innerstate, by contrast, does not mention the name of the drug, and even the name of the film’s producer, Centocor, is not revealed until the last line of the credits.

PhRMA should also investigate whether Centocor has complied with
Principle #2 on presenting a "balance of risks and benefits" about the advertised drug;
Principle #11, that "risks and safety information .. should be presented in clear, understandable language, without distraction from the content"; and
Principle #15, on providing information "about help for the uninsured and underinsured."

[Some stuff about prior history omitted; you can read the entire letter here.]

We ask that PhRMA thoroughly investigate Innerstate and Centocor’s marketing of the movie, and pursue all appropriate remedies that address the practices of its member Johnson & Johnson and its subsidiary Centocor.

Good luck with that! First, PhRMA's Office of Accountability has not been very effective in enforcing its DTC Guidelines (for more on that, see "Adventures of PhRMA Intern!").

I wasn't at the King of Prussia showing of INNERSTATE and I cannot verify that the Medication Guide I received with the DVD is the same as the Viewer's Guide mentioned in the Local 32BJ letter to PhRMA. All I can say is that if the two are the same, then the movie should be considered part of a branded campaign. If so, Centocor did include enogh information about side effects, etc. to comply with FDA regulations and PhRMA DTC Guidelines.

The question is NOT did Centocor violate FDA or PhRMA Guidelines. Rather, should INNERSTATE be considered branded or unbranded promotion?

The Innerstate DVD. Is TV Next?

NOTE: Please see the follow-up post, "Innerstate: A Correction and Further Criticisms."

Depending upon how well a Hollywood movie does at the box office, it usually takes six months or more before the DVD version is released and maybe a year before you can see it on paid TV channels like HBO.

By that standard, Centocor's 58-minute disease awareness documentary INNERSTATE must not be doing too well in theaters: less than three months after the movie debuted in New York City, the INNERSTATE DVD arrived in my mailbox. I had signed up to attend a live presentation of the movie at the King of Prussia Mall in Pennsylvania, but decided not to go. After all, I already had a private screening (see "Innerstate Private Screening: Philadelphia Style").

INNERSTATE is about patients suffering from psoriasis, Crohn's disease, and rheumatoid arthritis, which, coincidentally (not), are three of the indications for Centocor's biologic drug Remicade. The drug name is not mentioned in the movie, which is considered a "disease awareness" promotion by Centocor. As with all such disease awareness programs, INNERSTATE is designed to fit into an overall marketing strategy whose goal is to increase sales of product. I'll explain below how Centocor links the movie to the product.

Some might argue that pharma companies have limited time to make hay out of their promotional efforts before patent expiry of their products and therefore you cannot compare Hollywood blockbuster movie time lines with Rx drug blockbuster time line. However, Hollywood movies have even shorter shelf lives than Rx drugs. [In case you are interested in more comparisons between Hollywood movie production and promotion and blockbuster drug production and promotion, please see "Movies and Drugs: Same Blockbuster Mentality".]

INNERSTATE -- The TV Show?
Any way, if the analogy with blockbuster movies holds, I expect to see INNERSTATE on TV in the fall. Probably on PBS. Recall that other pharmaceutical companies have provided educational grants to independent producers to support disease education documentaries on PBS. GSK, for example, provided funding for the PBS show "Fat: What No One is Telling You." GSK is marketing the over-the-counter weight loss product Alli (see "Alli Oops! I Just Pooped Myself!").

[I think it's interesting that FDA approved GSK's "Alli" but balked at Sanofi-Aventis' use of "Acomplia" as a name for its drug. I guess a drug can be your "ally" but not promise that such an alliance will "accomplish" much. The best analogy I can use is the alliance between the US and UK in Iraq, in which endeavor France was definitely not an ally.]

Will the INNERSTATE movie appear on European TV first?
According to a recent article in the Guardian:

"Four of the world's biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines."

Under the proposals, viewers could use their remote control to click on treatment options and read what manufacturers have to say about the latest branded drugs.

The four companies are Johnson & Johnson (parent company of Centocor), Pfizer, Novartis and Procter & Gamble.

Centocor already has devised a way to link the unbranded movie INNERSTATE with branded information about Remicade, although not in the high-tech fashion proposed for "Pharma TV' (maybe that's in the cards for the EU version).

Finally, the DTC Advertising is Delivered!
The INNERSTATE DVD came with a letter from Thomas Schaible, VP of Medical Affairs at Centocor. Dr. Schaible urges me to "talk to a doctor to learn if biologic therapy is an appropriate treatment option."

None of this -- not the movie, not the DVD, and not the letter -- is considered direct to consumer (DTC) advertising and none of it is subject to FDA regulation. That's because no brand name drug is mentioned. Although not required by law, the movie does mention side effects of "biologic treatments."

Side effects are a major focus of the product labeling for Remicade. I discovered the Remicade labeling, which was a huge sheet of paper (about 13" x 30") covered front and back with small print, in the DVD box. It includes a "black box" warning, which tells of possible side effects of treatment, including "serious infections leading to hospitalization or death,' tuberculosis, and heptasplenic T-cell lymphoma (cancer).

At first, I was surprised to see the product labeling in the DVD box because neither the movie nor the cover letter mention Remicade by name. Therefore, no product labeling is required. But then I looked more closely at the 41-page "Viewer's Guide" that also came with the DVD. More than half of this booklet is devoted to a "Remicade Medication Guide." This glossy bit of collateral closes the circle between the "disease awareness" movie and branded DTC advertising.

The Protest
Unfortunately, I missed a bit of entertainment by deciding not to view the movie at the King of Prussia Mall -- and I'm not talking about the movie itself. Apparently, protesters demonstrated at this showing as they have been doing at other showings of the movie in other states.

These protests are carried on by Service Employees International Union Local 32BJ, which also has filed a lawsuit against J&J that charges the company used pricing and marketing practices that lead to excessive reimbursements by Medicare, private insurers, and patients. In documents filed in connection with the case, J&J admitted to publishing "average wholesale prices" (AWP) that are above the real cost of medications.

The union claims that the artificially high AWP means that they end up paying 30% more for Remicaid than physicians.

One Little Disappointment: Lack of Transparency
When I inquired about the protest at the King of Prussia showing, a Centocor spokesperson shrugged it off as merely a union "labor issue" that had nothing to do with the movie or Remicade. He did not bother to mention the law suit and did not open the discussion on average wholesale pricing and the profits that physicians can reap merely by prescribing the product.

No wonder Centocor did not have to pay physicians to appear in the movie or to show up at the screenings!

Myth #1: High U.S. Drug Prices Guarantee Us First Shot at New Drugs

The drug industry often defends higher drug prices in the U.S. by claiming that it guarantees Americans "first shot" at new drugs.

Bob Ehrlich at DTC Perspectives stated as much in his e-mail commentary today:

"As far as high pricing goes, here is where it can get quite complex. Drug companies need someone to pay high retail prices, because so many countries have price controls. There is not really a palatable explanation to the American public on why drug prices are higher in the U.S. market. The truth is that someone needs to make drug sales profitable and unfortunately it is the American public that is hit with the tab. The benefit is more drug research and a market inspired guarantee that Americans will get first shot at newer drugs. We certainly will appreciate that when a pandemic hits."

[Bob, I'm sorry if I am quoting you out of context, but I can't link to an e-mail message. If your commentary had a Web page, I would be glad to provide the link.]

"Pandemic" fear mongering aside, after about 20 milliseconds I was able to think of at least one drug that has been available in Europe for at least a year and not yet approved for sale here in the US: Acomplia, or as it is now going to be called here in the US, Zimulti (see "Yummi! It's Zimulti!").

Not that I think this is such a great product, but it is representative of a common practice by the drug industry: launch new products outside the US first, then get US FDA approval later.

I am not sure how "common" this practice really is, but I think it's likely to be more common now that the FDA seems more cautious in approving new drugs (see, for example, "Our Lawless FDA"). Having a drug already on the market in Europe, Asia, and South America is a good argument for approving it for sale in the US, all other things being equal.


Just a thought: What Americans may sometimes get by paying higher prices for Rx drugs is the comfort in knowing that we are not the guinea pigs; other people are. That's priceless!

Mr. Moore Don't Ignore: Please Invite Me to a Screening of Your Movie

Dear Mr. Moore:

I hear that your new documentary SICKO about the pharmaceutical-health-insurance-industry complex is set to debut in Cannes, France (see "SiCKO Debuts At Cannes On Saturday").

I would very much like to see this movie, but I cannot afford to go to Cannes. Also, I sent in my passport for renewal and won't get it back in weeks!

Anyhoo! I really think you should invite us bloggers to a special screening of your movie. After all, Centocor -- part of the J&J pharmaceutical family -- was nice enough to invite me to a special screening of THEIR movie "Innerstate" (see "Innerstate Private Screening: Philadelphia Style"). As a result, I've treated them really nicely and wrote an article praising the movie in my newsletter (see "Innerstate: The First Disease Awareness Documentary Film"), etc.

I can do the same for you! I am already a fan of yours.

If you don't invite me, I'll have no recourse but to compare your slight to bloggers with Centocor's (a J&J company) open invitation. Imagine the headlines: "Moore Ignores Bloggers" and the crux of the story: "While J&J, one of America's biggest pharmaceutical companies, embraces bloggers, Michael Moore, self-proclaimed champion of the common man, ignores this influential group of industry critics."

You can avoid all that bad press by inviting me -- an industry "critic" who's really on your side (I think; I'll reserve judgment until I see the movie) -- to a private screening.

But, please, make it easy for me. I could come to your place in New York or maybe you can find some neutral place to do the screening (not Philadelphia, please). You can even invite my blogger buddies -- I'll be glad to recommend who to invite.

Of course, you should have food there -- hire one of those firms that cater lunches for the stars while on set. BTW, that would beat what Centocor offered, which was bottled water!

I look forward to your response. Call me any time at 215-504-4164 or e-mail me at johnmack@virsci.com

Sincerely,

John Mack

When is a Free Lunch More Than Just Lunch?

Time and time again, when I write about physicians getting free lunches delivered by sales reps, someone always comes forward and says something like "It's ridiculous to think that I can be influenced by a $10 lunch!"

For some physicians, however, a free lunch has a much greater value than its monetary worth. Take this comment, for example, that I received to the post "Blog Readers' Opinions on Physician Marketing & Education Practices":

"I would just like to say that as a former intern and resident working 100-hour weeks while making less than $30K a year, a free lunch now and then was a godsend and brightened up otherwise long and dreary days."

"Seriously, though, I do understand why institutions are moving toward these 'No Free Lunch' things, but really, cut the scut workers a break every now and then. If you've been there, you know how it sucked and how a free lunch was like having recess."

This anonymous commenter then went on to say: "Neither I, nor anyone I trained with was ever even remotely influenced by a drug lunch (N = at least 100)"

I won't quibble about how this person knows what influences or does not influence other people like his/her colleagues.

From these comments, however, it appears that a lunch is not just a lunch, but, in some cases, it's like "recess" at school or a "godsend."

This really puts into perspective the true value of a "free" lunch, which may be many times the monetary value. How can you place a value on a "godsend?" It's priceless!

From that perspective, I believe it's more likely than ever that free lunches can unduly influence physicians, regardless of the debatable contention that dozens of these lunches have not influenced the particular physician who made the above comments.

But this physician/commenter may just be a pizza fanatic: "The very thought of changing lunches from pizza to something healthy is heresy," according this person.

No Goopy ED Gel in GSK's Futura

According to the Financial Times, GlaxoSmithKline unexpectedly handed back the development rights to Futura's erectile dysfunction gel, a sample of which is shown on the left (just kidding! See story here.)

"The drug, which has completed Phase II trials, would have been an alternative to Viagra, the current market leader developed by Pfizer."

"We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into," GSK said.

Let me guess why this gel, if it were developed, may not be a commercial success. A gel may have some utility among solo sexual aficionados who would benefit from the gel's dual action as an penile enhancer and a lubricant, but I imagine things could get a bit sloppy during normal male-female bilateral sexual encounters.

Obviously DTC ads could not be targeted to the solo sex male practitioner -- it just wouldn't fly in Peoria (or Congress).

Blog Readers' Opinions on Physician Marketing & Education Practices

According to a Government Accounting Office (GAO) report, pharmaceutical companies spend approximately 70% more money marketing to physicians than they do to consumers (see chart; click to enlarge).

The physician promotional data includes estimated spending on office and hospital-based promotion to physicians and journal advertising. These estimates do not include other spending, such as drug company spending on meetings and events (eg, CME and advertising at CME events, which could be as much as $1.5 billion). It also does not include fees paid to physicians for participating in post-marketing studies or for "consulting." As I pointed out previously (see "Dollars for Docs: More Scrutiny Needed"), some of these fees can be substantial.

Regular readers of Pharma Marketing Blog know that from time to time I host little opinion polls on various topics. In case you missed these polls, I have placed them in the column on the left. A new poll is reloaded every time to refresh the page.

Several polls on this blog addressed pharmaceutical physician marketing and education practices and the results to date are shown in the figure below.

Whoops! Wrong figure. That's the infamous bikini-clad sales rep (see here for that story).
See chart below for poll results.

The Necessity of Sales Reps
A big slice of the physician promotion pie goes towards supporting field-based sales reps. The average cost of a sales call by a rep may range from $200 to $500 (see "What Is Average Cost of Sales Call?").

What absolutely essential need does the rep fulfill? I originally asked this question back in January (see "Are Sales Reps Necessary?"). This got me banned from Cafe Pharma (see "Banned from CafePharma!"), but it was worth it to raise the issue and get feedback from readers (see poll results at top of chart above).

Surprisingly, almost twice as many votes were cast agreeing that pharma sales reps are unnecessary for any of the listed functions than votes agreeing that they were needed for all the listed functions (14% vs. 8%).

While "Source of Practical Information for Docs" got the most votes, I think this is not an "essential" function of sales reps. After all, physicians have multiple ways of getting drug information, including the Internet. However, I do see the utility of getting right in front of the doc and shoving the information in his/her face.

Free Lunches
Only 9% of the votes cast agreed that reps served an essential function by serving free lunches to physicians. In another poll (second from top in the chart above), a clear majority (62%) of respondents agreed that pharma should STOP serving free lunches altogether.

If pharma can't stop the lunches, then I suggest they serve healthy lunches instead of pizza and cupcakes. What kind of message does that menu send, especially to patients who see the food being rolled by them in the waiting room?

Soon, I expect pharma to start serving lunches to patients as well (see "Free lunch for patients! Why not?").

Consultant Fees
While pharma is being pressured to reveal who gets continuing medical education (CME) grants, a lot more money may be going to physicians as paid "consultants" (see "Dollars for Docs: More Scrutiny Needed").

A very large majority (71%) of respondents to a poll agree that the public has a right to see which physicians get consultant fees, for what and how much they get (see poll results at the bottom of the chart above).

To sum up, if reader opinion means anything, pharmaceutical companies should stop giving physicians free lunches and they should make public the consulting fees they pay to docs.

I respectfully await your rants!

Blogs vs. DTC: What's Best for Consumers?

The recent DTC moratorium scare from Congress -- which has since dissipated (see "DTC Moratorium Yanked From PDUFA") -- had Direct-to-Consumer (DTC) marketers scrambling to think of a replacement consumer marketing strategy. In that scramble, blogs leaped to mind.

One such mind was that of Bob Ehrlich, Chairman at DTC Perspectives, Inc., who writes a weekly e-mail commentary on trends in DTC. His May 4, 2007 piece entitled "Blogs and DTC" posed an interesting question:

"While [blogging is] now aimed primarily at industry insiders, one has to wonder when it will be a dominant consumer tool aimed at reviewing drug performance, side effects and risks. Blogs on drug selection may soon be a key tool in spreading word of mouth on new drugs."

Ehrlich was thinking about how pharmaceutical marketers can use blogs to "spread the word" in the future when DTC might be banned. "I am not exactly sure how, as a marketer, to incorporate blogs in my brand plans," said Ehrlich. "You cannot control them or measure them as with other media."

While pharma marketers are stymied by blogs and trying to work out a strategy for using blogs and other "Web 2.0" technologies to promote products, consumers and physicians are already discussing drugs in their own blogs and related social networks.

There are blogs written by physicians focused on drugs. An example is CL Psych, which is written by "an academic with a respectable amount of clinical experience and no drug industry funding. Certain things about clinical psychology, the drug industry, psychiatry, and academics drive me nuts," says this anonymous blogger.

Consumers and patients also write blogs. A good example of such a blog is Diabetes Mine, written by Amy Tenderich, a person with Type I diabetes. Amy covers more than just drugs in her blog, but a recent post entitled "Januvia: Is It 'Oral Byetta' or Just a Lucky Break?" is an example of what the pharmaceutical industry must contend with.

A few months ago, I pointed out that Revolution Health, a new social networking site founded in 2005 by Steve Case (former CEO of AOL), was poised to pit the "wisdom of the crowd" against the BS of drug marketers (see "Revolution Health and the Wisdom of Crowds"). On the site visitors can rate Rx drugs according effectiveness, side effects, ease of use, and cost effectiveness.

On this site you can see what many people are saying about specific drugs. You can find Viagra's rating here.

Listen to a Pharma Marketing Talk interview with Jay Silverstein, the COO of Revolution Health, about its new health portal web site. Will pharmaceutical marketers warm up this site for advertising and sponsorship opportunities? See "Revolution Health and the Wisdom of Crowds."

Web 2.0 technology like Revolution Health and blogs is still in its infancy. But over time it could become become a more powerful influencer than DTC.

"In this new world of blogging," says Ehrlich, "drug companies are going to have to deal with a high volume of unregulated drug information. Just keeping a tab on what is being said probably takes a full time person screening the major blog sites. Like it or not drug companies will be forced to respond to a blogger story. After all, blogs multiply and will not just die like the good old days of a bad network news story."

I have many questions for Mr. Ehrlich about Blogs and DTC. I decided, therefore, to invite him to be a guest on my May 24, 2007 Pharma Maketing Talk podcast entitled "Blogs vs. DTC: What's Best for Consumers?"

Some questions I intend to ask include:

• Are consumers turning towards blogs to get information about drugs and medical treatment options? Are these primarily patient/consumer blogs or also physician blogs?
• Are blogs inherently less credible than other sources of drug information on the Internet? If so, how so?
• Many patient blogs offer opportunities to be "harnessed" by pharmaceutical marketers. What dangers do marketers face when getting involved in the blogosphere either by placing ads on blogs or more pro-actively engaging in the conversation?
• How can pharmaceutical companies relinquish some control over content to enable to better co-operate with bloggers?

If you have any questions you'd like me to include in our discussion, let me know by posting a comment to this post. You can also listen in to the live podcast and call in with your questions. For more information, go here.

Are Critical Bloggers "Enemies" of Pharma?

More and more attention is being paid to bloggers in the Pharma Blogospher^TM. There are currently several means of keeping track of all the comings and goings of blogs in this space, including:

The Pharma Blogosphere Blog: Created by John Mack, this blog offers reviews of blogs and blog postings, reader surveys, and a critical look at blogging practices and the growing interest in these blogs by the pharmaceutical industry.

Pharmacentral Pageflakes: Created by Steve Woodruff who also blogs at Impactiviti, this portal is designed to give you fingertip access number of targeted blogs, so that you can more easily and quickly find updated commentary on a variety of topics. It organizes blogs by topic areas like news, marketing & training, gossip, public policy, etc. Each blog appear as a "flake" (a feed summary) showing recent posts made to the blog.

Pharmagather: This is another site that gathers feeds from blogs and displays them in chronological order -- the most recent posts at the top.

Pharma Blogs: Week in Review: An weekly e-mail newsletter from the editors of MedAdNews, it summarizes selected topics covered by pharma blogs in the past week.

Contrary to industry expectations or fears, not all pharma blogs are critical of the industry. This was revealed by the First Ever Pharma Blogosphere Readers Survey, a summary of which you can find here.

In that survey, I was careful NOT to characterize pharma blogs as "friends" or "foes" of the drug industry. Readers were asked to rate blogs according to how "supportive" or "critical" they were of the industry.

Recently, the Prescription Access Litigation (PAL) Blog, entered the Pharma Blogosphere (see "New Pharma Blog Planet Discovered"). This blog was not rated in the survey, but Jim Edwards over at BrandweekNRX took it upon himself to label the PAL blog as a "pharma enemy" (see "More of Pharma's Enemies Join the Blogosphere").

Frankly, I don't think PAL is an industry supporter, but "enemy" may be too strong a word.

Are you an "enemy" if you challenge the drug industry's illegal practices, which is the stated mission of PAL? If so, then many of us are "enemies" of pharma at one time or another.

PAL's tactics may help some lawyers get rich, but sometimes lawsuits are the only recourse to correct illegal practices committed by corporations in the US (the recent Purdue settlement with the DOJ is a good example).

But Edwards goes even further by hinting that PAL's entrance to the Pharma Blogosphere is an example of "more" pharma enemies blogging. This implies that there are currently other "enemies" in this space. I am not sure who Edwards has in mind for these other "enemies"; maybe he should just come out and say who he means.

I'm not saying that Edwards considers this blog an "enemy" of pharma, but he has definitely cast a pall over my efforts to improve pharma marketing practices and the reputation of the industry.

It's time that the industry stop labeling critics as "enemies" and circling the wagons. Instead, I suggest we step back from such labels and focus on taking a critical look at illegal, unethical, and ill-conceived practices.